BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25233029 · Received May 20, 2026

    Report

    Report Number
    1220648-2026-08040
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    May 14, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY IN A 73-YEAR-OLD MALE PATIENT FOR THE INDICATION OF PROTECTED PERCUTANEOUS CORONARY INTERVENTION IN THE SETTING OF ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK. THE PATIENT¿S COMORBIDITIES WERE NOT REPORTED. THE PATIENT¿S CLINICAL STATE PRIOR TO INITIATION OF SUPPORT WAS IDENTIFIED AS SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE C CARDIOGENIC SHOCK. FOLLOWING CONFIRMATION OF PURGE SOLUTION EXITING THE OUTLET CAGE, THE IMPELLA CP DEVICE WAS INSERTED AND SUPPORT WAS INITIATED. SHORTLY AFTER INITIATION OF SUPPORT, THE AUTOMATED IMPELLA CONTROLLER DISPLAYED HIGH PURGE PRESSURE AND PURGE SYSTEM BLOCKED ALARMS. INITIAL ASSESSMENT CONSIDERED THE POSSIBILITY OF EXTERNAL TUBING OBSTRUCTION DUE TO DIFFICULTY ENCOUNTERED UNWRAPPING AND ORGANIZING THE PURGE LINE AND CONNECTOR CABLE; HOWEVER, NO VISIBLE KINKS WERE IDENTIFIED. DE-AIRING OF THE PURGE SYSTEM WAS PERFORMED WITHOUT RESOLUTION OF THE ALARMS. CUSTOMER SUPPORT CENTER WAS CONTACTED FOR TROUBLESHOOTING GUIDANCE, AND THE AUDIO ALARM WAS SILENCED WHILE THE DEVICE REMAINED IN USE FOR THE PERCUTANEOUS CORONARY INTERVENTION, WITH PHYSICIAN AWARENESS OF THE ONGOING CONDITION. THE PHYSICIAN ELECTED NOT TO ADMINISTER SYSTEMIC HEPARIN OR OBTAIN ACTIVATED CLOTTING TIME MEASUREMENTS, AS THE PATIENT WAS RECEIVING BIVALIRUDIN INFUSION. DURING THE PROCEDURE, IMPELLA FLOW, MOTOR CURRENT, AORTIC, AND LEFT VENTRICULAR WAVEFORMS WERE OBSERVED TO BECOME SATURATED AND INCONSISTENT WITH EXPECTED PERFORMANCE. THE FINDINGS WERE COMMUNICATED TO THE PHYSICIAN, AND THERE WAS CONCERN FOR DEVICE FUNCTION AND REPORTED AS "SOME PUMP INGESTION." A TRANSIENT PUMP STOP ALARM WAS SUBSEQUENTLY OBSERVED, ASSOCIATED WITH A DECREASE IN FLOW, WHICH THEN RESOLVED. IN THE SETTING OF PERSISTENT PURGE SYSTEM ALARMS, ABNORMAL WAVEFORM BEHAVIOR, AND CONCERN FOR DEVICE PERFORMANCE, THE CLINICAL TEAM MADE THE DECISION TO REMOVE THE IMPELLA CP DEVICE DURING THE PROCEDURE. ECHOCARDIOGRAPHIC EVALUATION DID NOT IDENTIFY LEFT VENTRICULAR THROMBUS. UPON DEVICE REMOVAL, BIOMATERIAL WAS REPORTED TO BE PRESENT IN THE OUTFLOW. THE REPORTED EVENTS, INCLUDING ELEVATED PURGE PRESSURE, PURGE SYSTEM BLOCKED ALARMS, ABNORMAL WAVEFORMS, AND PRESENCE OF BIOMATERIAL, ARE CONSISTENT WITH POTENTIAL OBSTRUCTION OR INGESTION WITHIN THE PUMP SYSTEM DURING MECHANICAL CIRCULATORY SUPPORT. THESE FINDINGS MAY OCCUR IN THE SETTING OF HEMOCOMPATIBILITY-RELATED FACTORS AND PROCEDURAL CONDITIONS DURING HIGH-RISK PCI IN A PATIENT WITH CARDIOGENIC SHOCK. ADDITIONAL INFORMATION WAS RECEIVED. THE PUMP STOPPED. AN ALARM APPEARED AND THEN WENT AWAY WITH RETURN OF FLOWS. THE PUMP WAS RETAINED AND WILL BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512983 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027864746 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention